Role of FXR in Hepatitis C Virus Replication

Not Applicable

Terminated

• Conditions: Chronic Hepatitis C
• Interventions: Other: guggulsterone, a natural FXR antagonist.

• Registration Number: NCT01492998
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

In vitro in the hepatitis C virus (HCV) replicon system, modulation of the biliary salts nuclear receptor FXR by either agonists or antagonists respectively increases or decreases the replication of HCV (J Hepatol, 2008, 48: 192-9). One antagonist of FXR is a vegetal sterol, guggulsterone, that is extracted from the Commiphora mukul tree and that has already been given safely to hyper cholesterolemic patients in a clinical trial (JAMA 2003, 290: 765-72). The aim of this trial is to test the effect of the FXR antagonist guggulsterone given orally, three times a day, on the viral load in 15 HCV genotype 1 chronically infected patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2010-03
• Status Verified: 2010-09
• Study First Submitted: 2010-09-23
• Study First Submitted QC: 2011-12-14
• Last Update Submitted: 2011-12-14
• Study First Posted: 2011-12-15
• Last Update Posted: 2011-12-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

• Male patients infected by HCV genotype 1, with anti-HCV antibodies, non responders to at least one first line of therapy
• Viral load > 1 x 105 UI/mL for more than 6 months and not treated for at least the last two months.
• METAVIR score < F4

Exclusion Criteria

• Alcohol intake > 20 g/day
• Immuno - suppressive therapy
• Obesity BMI > 30, diabetes
• Dyslipidemia requiring specific therapy
• Liver cirrhosis or carcinoma
• HIV or HBV co-infections
• Other liver diseases
• Major organ failures
• Therapy with cytochrome P450 metabolized drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Guggulsterone	guggulsterone, a natural FXR antagonist.	One arm of 15 chronically HCV genotype one infected patients

Primary Outcome Measures

Name	Time	Method
Evolution of the HCV plasmatic viral load while taking the FXR inhibitor guggulsterone.	One week

Secondary Outcome Measures

Name	Time	Method
Modification of the fraction of the circulating viral forms associated with apolipoprotein B	One week

Trial Locations

Locations (1)

Department of hepatology, Hospices Civils de Lyon, Hôtel Dieu; 🇫🇷 Lyon, France